In the field of laryngectomy a voice prosthesis is often used for tracheoesophagal speech. The voice prosthesis is then placed in a puncture in the tracheoesophageal wall. The voice prosthesis may be placed in said puncture directly after the voice box is removed and the trachea is sutured to the skin of the neck—so called primary puncture—or after time of surgery, under general anesthesia—so called secondary puncture. A voice prosthesis has a tubular body, with a flange in each end. The tubular body is to be mounted in the tracheoesophageal wall with a flange situated on the tracheal side, substantially hindering movement of the voice prosthesis into the oesophagus, and the other flange situated on the oesophagal side, hindering movement of the voice prosthesis into the trachea. A valve member is located in the lumen of the tubular body. The voice prosthesis may also be provided with a safety strap, arranged on the flange intended to be situated on the tracheal side.
Laryngectomy is in most cases performed in cases of laryngeal cancer.
To create a tracheoesophageal puncture during primary puncture, a pharynx protector is inserted in the esophagus until the tip of the pharynx protector reaches the intended puncture site. The pharynx protector is a hollow, rigid, and cylindrical device with a handle. It is inserted in the pharynx/esophagus to protect the posterior wall during puncture. The tip of the device has normally an oblique opening, which is palpated by the surgeon to verify the correct position for puncture. The tip of the pharynx protector is palpated through the tracheoesophageal wall to verify the correct placement of the puncture. The puncture is made with a troachar through the tracheoesophageal wall against the pharynx protector. The troachar is a thick and hollow instrument, normally made of stainless steel. The troachar is used to create the puncture and to facilitate the subsequent introduction of a guide wire, which is inserted through the hollow part of the troachar.
The guide wire may be a flexible plastic tube, which is plastically deformable. The troachar may have a bent tip in order to direct the guide wire into the hollow cylindrical part of the pharynx protector. The troachar is oriented so that a bent tip thereof directs a guide wire—subsequently inserted through the troachar—into the lumen of the pharynx protector. Next, the guide wire is introduced through the troachar until the distal tip of the guide wire extends approximately 20 cm through the pharynx protector. The troachar and the pharynx protector are removed, leaving the guide wire in place through the puncture of the tracheoesophageal wall. Thereafter, a voice prosthesis is arranged on the guidewire and pulled through the tracheoesophageal puncture.
During secondary puncture a rigid esophagoscope is generally inserted in the esophagus instead of a pharynx protector until the tip of the esophagoscope can be palpated at the puncture site. The puncture is then made with the troachar against the esophagoscope which acts as a pharynx protector.
U.S. Pat. No. 6,159,243 discloses a voice prosthesis implantation kit including; a leader element, which can be introduced via the mouth to the location where the voice prosthesis is to be implanted; a hollow cutting element for cutting the wall of oesophagus, said leader element having a first coupling device in one end; a guide element, which in one end may be coupled to said first coupling element, and in the other end carrying an dilator for a voice prosthesis. The dilator may be screwed into engagement with the guide element, said guide element having a cavity in the other end thereof, in which cavity the voice prosthesis may be mounted by pushing a flange of the voice prosthesis into the cavity. The kit according to U.S. Pat. No. 6,159,243 is only usable for secondary puncture; the voice prosthesis can not be pre-loaded in the dilator, since one of the flanges is pushed into the cavity of the voice prosthesis, whereby the risk of plastic deformation is high; the guide element is screwed into engagement with the dilator in the thin end of the dilator, putting high demands on attachment mechanism, since the pulling of the kit through the puncture wants to depart the dilator from the guide element. Also, since the kit according to U.S. Pat. No. 6,159,243 is adapted to pull the voice prosthesis through the neck into position, it is impossible to control if the inner flange is fully unfolded on the oesophagal side. Furthermore, as the oesophagal flange is folded and pushed into a gripping cavity keeping the flange in folded position, the holding force is very limited. Thus, the risk of disengagement between the cavity and the voice prosthesis is quite high; especially, since the flange of the voice prosthesis is of a substantially flexible material.
Hence, an improved inserting system would be advantageous, and in particular a dilator allowing for use in both primary and secondary puncture; allowing for pre-loading of the voice prosthesis in the dilator prior to usage, i.e. a dilator not risking plastic deformation of flanges on the voice prosthesis; a dilator allowing for a more effective and easy to assemble attachment mechanism between the dilator and the guide wire, would be advantageous.